MSAT Associate Principal Scientist

ppFor our client, a global leader in biopharmaceutical manufacturing, we are seeking an experienced /p h3MSAT Associate Principal Scientist (m/w/d) /h3 h3General Information /h3 ul libStart Date: /b /li libDuration: /b 7 months /li /ul h3Tasks Responsibilities /h3 ul liDefine and implement process validation strategies for microbial and biopharmaceutical manufacturing processes in compliance with Validation Master Plans (VMPs), SOPs, and regulatory requirements. /li liAuthor, review, and maintain process validation documentation, including study designs, protocols, reports, and process validation lifecycle documentation. /li liDevelop and maintain Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight and lifecycle management. /li liSupport process characterization activities, assess validation data, and collaborate with RD and cross-functional teams to ensure successful execution of validation activities. /li liCoordinate change controls and deviations, support investigations, define corrective actions, and participate in cross-functional risk assessments. /li liAct as the process validation subject matter expert during customer audits, health authority inspections, and validation-related Quality activities. /li liSupport validation training initiatives and drive effective collaboration between MSAT, QA Validation, Cleaning Validation, QA Qualification, and other key stakeholders. /li /ul h3Your Profile /h3 ul liBachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related Life Sciences discipline. PhD preferred. /li li5-10 years of experience in biopharmaceutical manufacturing environments. /li liStrong experience in process development, process validation, and MSAT environments. /li liIn-depth understanding of Process Validation Lifecycle, Continued Process Verification (CPV), and Product Quality Reviews (PQRs). /li liSolid knowledge of GMP requirements and regulatory expectations for biologics and microbial processes. /li liExperience supporting audits, inspections, deviation management, and change control activities. /li liBusiness fluency in English; German is advantageous. /li /ul /p #J-18808-Ljbffr